Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-0958-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.

Product Classification:

Class II

Date Initiated: December 28, 2012

Date Posted: March 27, 2013

Recall Number: Z-0958-2013

Event ID: 64162

Reason for Recall:

Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.

Status: Terminated

Product Quantity: 57,962 units (50,452 units in the US)

Code Information:

All

Distribution Pattern:

Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.

Voluntary or Mandated:

Voluntary: Firm initiated